TAP vs QLB in Patients After Cesarean Delivery
Primary Purpose
Cesarean Section, Postoperative Pain
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
TAP (transversus abdominis plane block)
QL (quadratus lumborum block)
Ropivacaine
Needle
paracetamol
metamizole
Ketoprofen
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Cesarean Section focused on measuring transversus abdominis plane block, quadratus lumborum block, neuropathic pain
Eligibility Criteria
Inclusion Criteria:
- obtained consent
- singleton pregnancy
- subarachnoid anesthesia
Exclusion Criteria:
- coagulopathy
- allergy to local anesthetics
- depression, antidepressant drugs treatment
- epilepsy
- usage of painkiller before surgery
- addiction to alcohol or recreational drugs
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TAP
QLB
Arm Description
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
Ultrasound-guided quadratus lumborum block at the end of cesarean section
Outcomes
Primary Outcome Measures
Postoperative pain
Acute pain measured with VAS (visual-analogue scale). VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.
Secondary Outcome Measures
Neuropathic pain
Neuropathic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain.
Full Information
NCT ID
NCT03404908
First Posted
January 12, 2018
Last Updated
January 19, 2018
Sponsor
Medical University of Lublin
1. Study Identification
Unique Protocol Identification Number
NCT03404908
Brief Title
TAP vs QLB in Patients After Cesarean Delivery
Official Title
Postoperative Analgesia With Transversus Abdominis Plane Block or Quadratus Lumborum Block in Patients After Cesarian Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2018 (Anticipated)
Primary Completion Date
January 14, 2019 (Anticipated)
Study Completion Date
April 17, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lublin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of two types of analgesia after cesarean section All patients will be anesthetized with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will be measured with visual-analog scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).
Detailed Description
Written consent will be obtained before the cesarean section. Only subarachnoidally anesthetized patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.
At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.375 % ropivacaine) on each side.
Postoperative pain will be measured with VAS (visual-analog scale) 2, 4, 8, 12 and 24 hours after the end of the operation.
Paracetamol, metamizole, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day).
1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Postoperative Pain
Keywords
transversus abdominis plane block, quadratus lumborum block, neuropathic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
Single (Participant)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAP
Arm Type
Experimental
Arm Description
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
Arm Title
QLB
Arm Type
Experimental
Arm Description
Ultrasound-guided quadratus lumborum block at the end of cesarean section
Intervention Type
Procedure
Intervention Name(s)
TAP (transversus abdominis plane block)
Intervention Description
the ultrasound-guided regional block of abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375% ropivacaine administered (0.2 mL/kg).
Intervention Type
Procedure
Intervention Name(s)
QL (quadratus lumborum block)
Intervention Description
the ultrasound-guided regional block of abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with a distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
In both groups (TAP&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)
Intervention Type
Device
Intervention Name(s)
Needle
Intervention Description
Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention Description
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
Intervention Type
Drug
Intervention Name(s)
metamizole
Intervention Description
Intravenous metamizole will be used (1.0 gram), up to 4 grams per day
Intervention Type
Drug
Intervention Name(s)
Ketoprofen
Intervention Description
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Acute pain measured with VAS (visual-analogue scale). VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.
Time Frame
up to 24 hours after the surgery
Secondary Outcome Measure Information:
Title
Neuropathic pain
Description
Neuropathic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain.
Time Frame
6 months from the surgery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
parturients
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
obtained consent
singleton pregnancy
subarachnoid anesthesia
Exclusion Criteria:
coagulopathy
allergy to local anesthetics
depression, antidepressant drugs treatment
epilepsy
usage of painkiller before surgery
addiction to alcohol or recreational drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michał Borys, M.D., PhD
Phone
+ 48 506350569
Email
michalborys1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Paweł Piwowarczyk, M.D., PhD
Phone
+48 511285352
Email
piwowarczyk.pawel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirosław Czuczwar, M.D., PhD
Organizational Affiliation
Medical University of Lublin
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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TAP vs QLB in Patients After Cesarean Delivery
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